Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- BXHGauge, Gas Pressure, Cylinder/Pipeline1Product Code
- BXMStimulator, Nerve, Ac-Powered2Product Code
- BXNStimulator, Nerve, Battery-Powered2Product Code
- BXOTransducer, Gas Pressure1Product Code
- BXPTransducer, Gas Flow1Product Code
- BXXCalibrator, Pressure, Gas1Product Code
- BXYFlowmeter, Calibration, Gas1Product Code
- BYMTube, Thorpe, Uncompensated1Product Code
- BYRTransducer, Gas Pressure, Differential1Product Code
- BZQMonitor, Breathing Frequency2Product Code
- CANRegulator, Pressure, Gas Cylinder1Product Code
- K162811MR Conditional CGA 8701Cleared 510(K)
- K080243PORTABLE OXYGEN UNIT SCA9001Cleared 510(K)
- K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATOR1Cleared 510(K)
- K061785CYL-FIL OXYGEN SYSTEM1Cleared 510(K)
- K950777OXYGEN REGULATOR1Cleared 510(K)
- K942751VANGUARD SERIES GAS REGULATORS1Cleared 510(K)
- K936187LSPI PRESSURE REGULATOR1Cleared 510(K)
- K9320061500 SERIES REGULATOR1Cleared 510(K)
- K921125AMBU OXYGEN REGULATOR1Cleared 510(K)
- K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS1Cleared 510(K)
Show All 55 Submissions
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2Product Code
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1Product Code
- CBAMonitor, Air Embolism, Ultrasonic2Product Code
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge1Product Code
- ECXCylinder, Compressed Gas, And Valve1Product Code
- FLSMonitor, Apnea, Facility Use2Product Code
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- KOIStimulator, Nerve, Peripheral, Electric2Product Code
- LKDMonitor, Carbon-Dioxide, Cutaneous2Product Code
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia2Product Code
- MNRVentilatory Effort Recorder2Product Code
- MRPAnalyzer, Nitric Oxide2Product Code
- MRQAnalyzer, Nitrogen Dioxide2Product Code
- NPFMonitor, Apnea, Home Use2Product Code
- PRKDevice Indicating An Exhalation Event2Product Code
- PUGAnalyzer, Nitrogen Dioxide, Exempt2Product Code
- PXEPressure Monitoring (Air/Gas) Kit1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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AMBU OXYGEN REGULATOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K921125
- 510(k) Type
- Traditional
- Applicant
- AMG, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/17/1992
- Days to Decision
- 191 days
- Submission Type
- Statement